Toripalimab-tpzi Development Program

Anti-PD-1 Monoclonal Antibody Toripalimab

Boosting the body’s immune response against cancer.

Monoclonal antibodies that target PD-1 or PD-L1 have been known to boost the body’s immune response against cancer cells. Anti-PD-1 antibodies have demonstrated effective treatment of several types of cancer, including melanoma of the skin, non-small cell lung cancer, kidney cancer, head and neck cancers, and Hodgkin’s lymphoma.

Toripalimab-tpzi is a next-generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types.

LOQTORZI™ (toripalimab-tpzi)

On October 27, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZI™ (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status. LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor. For more information, please see LOQTORZI.com for FDA-approved indications and full prescribing information.

Ongoing Clinical Development

Toripalimab-tpzi is the foundation of Coherus’ immuno-oncology pipeline which includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. We are currently exploring toripalimab-tpzi in combination with our TIGIT targeted antibody, CHS-006 and plan to explore combinations with other candidates in our portfolio including casdozokitug, a first-in-class anti-IL-27 antibody currently being evaluated in Phase 1/2 clinical trials in lung and liver cancer and CHS-114, a highly selective, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors.

More than 40 company-sponsored toripalimab clinical studies covering over 15 indications have been conducted globally by our partner Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.